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The Cyber-Spy.Com Usenet Archive Feeds Directly From The Open And Publicly Available Newsgroups These Group And Thousands Of Others Are Available On Most IS NNTP News Servers On Port 119. Cyber-Spy.Com Is NOT Responsible For Any Topic, Opinions Or Content Posted To These Or Any Other Newsgroups. This Web Archive Of The Newsgroups And Posts Are For Informational Purposes Only. Message-Id: <03092312014661.NP19605@jobcircle.com> Newsgroups: alt.bestjobsusa.computer,alt.bestjobsusa.computer.jobs,alt.bestjobsusa.jobs.offered From: adrian@medtalents.com (JobCircle.Com) Reply-To: adrian@medtalents.com Subject: US-MD: Baltimore-Process Engineer / Senior Process Engineer Date: Tue, 23 Sep 2003 12:01:46 GMT NNTP-Posting-Host: 207.106.112.162 NNTP-Posting-Date: Tue, 23 Sep 2003 08:01:46 EDT Organization: JobCircle.com (jobcircle.com) ************************************************************** JobCircle.com - Careers, Content and Community for Technology professionals in the Northeastern United States! Jobcircle.com provides resume submission, classified searches, eLearning, hundreds of career development articles, tech news, and more to tens of thousands of Technology professionals in your area - visit us today at http://www.jobcircle.com! !!! Voted a TOP 50 Career Web Site in 2002 by CareerXRoads !!! ************************************************************** Please reply to adrian@medtalents.com with your resume! Job Title: Process Engineer / Senior Process Engineer Job Location: MD: Baltimore Pay Rate: Open Job Length: full time Start Date: 2003-09-23 Company Name: MedTalents, Inc. Contact: Adrian Cuenca Phone: 201-384-7400 Fax: 201-385-8243 Description: Investigate all aspects of process by which human-bone-marrow aspirates are purified, cultured, and expanded into a human mesenchymal stem cell product for human therapeutic use. Select and optimize culture conditions including bioreactor system, environmental conditions, and other key parameters. Select and optimize cell harvest, washing, and transfer processes. Support technology transfer of process to manufacture and support the needs of quality systems and regulatory functions with written protocols and reports. Plan, carry out, analyze, and document experimental program to continuously improve and increase scale of process for manufacturing human mesenchymal stem cells for human therapy from human-bone-marrow aspirates. Work closely with process biologist in this task. Provide research and development guidance to manufacturing concerning current scheme of using robotics-supported 40-stack Nunc cell factories to produce hMSC product for clinical trials and commercial sale. Test various bioreactors and culture schemes for optimal combinations of product quality, identity, potency, yield, and manufacturability at required scale. Bioreactors may include robotics-supported 40-stack Nunc cell factories, perfusion reactors, packed or fluidized bead reactors, commercially available reactors, or feasible custom configurations. Work with vendors, search available products and current literature, and evaluate advantages and disadvantages of each system. Obtain laboratory data wherever possible on performance of systems to allow decisions to be made by experience. Transfer chosen process to manufacturing through a combination of verbal communication, hands-on training, written procedures and batch records, and written research and validation reports. Work closely with manufacturing personnel to ensure consistency of results among groups and successful operation of process in manufacturing. Design and support validation of scalable process which maximizes quality and yield of product while meeting or exceeding all product specifications for identity, potency, and quantity of product necessary to meet clinical trial and commercial goals. Ensure that process is designed for ease of manufacturing. Design and analyze experiments with an understanding of statistical hypothesis testing. Use appropriate control conditions and replication number to minimize experimental resources required while obtaining defensible results. Apply statistical design of experiments in cases where screening is required or a large number of experiments would be necessary using a classical design. When possible, apply trend analysis to experiments repeated over time in order to quantify process robustness and obtain early indications of process drift. Supervise, either directly or indirectly, research associates. Plan work, coach, provide feedback and guidance, and conduct or contribute to performance reviews. (Level and nature of supervisory responsibility depends on background of employee, current department staffing and organization, and other factors.) Develop working relationship with research personnel to be aware of discoveries and resources that impact development goals. Constantly be watchful for opportunities to incorporate research discoveries into development and manufacturing processes, and involve research when necessary in development or manufacturing troubleshooting. Work closely with personnel in quality systems and regulatory functions to contribute to FDA submissions, ensure that process is fully documented, and that all process steps can be performed to cGMP requirements in manufacturing. Support general company quality and regulatory initiatives. Maintain good lab housekeeping, good hygiene, and good safety practices at all time. Demonstrate good laboratory citizenship by assisting in lab stocking, cleanup, equipment maintenance, and other shared tasks. Participate in GMP manufacturing operations as needed to support clinical supply. Protect and add to the compans intellectual property by being vigilant for invention opportunities, by properly recording all work clearly in notebooks using company procedures for signing and dating pages and having them witnessed, and by filing invention disclosures when appropriate. Attend and participate in research and development seminars and conferences, both inside and outside the company, including analyzing and presenting work as requested. Prepare journal articles and meeting presentations when appropriate to further the companys scientific visibility and reputation. (All communications outside of the company should be made only after IP review.) Other duties as assigned. Compensation: $100,000 / Year (base) Experience: Ph.D. with 2-3 years experience or MS with 4-6 years experience, or BS with 8 or more years of experience in industry. Education and experience in biochemical engineering, bioprocess development, or related fields. This job has been posted on Absolutely Health Care to Allied Health: Laboratory. Please send to attention of Adrian Cuenca. Job Type: HealthCare Please refer to Job code 1661879 when responding to this ad. For FASTEST PROCESSING of your resume, please visit http://www.jobcircle.com/classifieds/430488.html to apply online. ************************************************************** For fastest processing of your resume, this employer asks that you apply to this job using the URL above. ************************************************************** Go Back To The Cyber-Spy.Com Usenet Web Archive Index Of The alt.bestjobsusa.jobs.offered Newsgroup |
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